I've been following your posts on iHub and Yahoo and your background and knowledge are impressive. I appreciate your input on AMRN and still hold a semi-large position based partly on your input.
Echo Therapuetics (ECTE) developed a skin permeation platform called Prelude which they licensed to Ferndale Pharmaceutical for the application of lidocaine in cosmetic skin procedures. In their presentation a claim is made that the current procedure is the application of a cream based lidocaine which takes up to an hour before the anesthetic takes effect. Lidocaine applied with the Prelude system becomes effective within 5 minutes. Ferndale is also targeting the pediatric market for vaccines and other injections.
The inventor of the Prelude technology is Dr. Robert Langer of M.I.T. (Langer Lab) who you’re probably familiar with. Dr. Langer is the Chief of the Scientific Advisory Board for Echo.
The cosmetic/pediatric market is estimated @ $1B+ but the real nugget is the diabetic market. Echo’s other product using the same skin prep platform is called Symphony. Symphony is a wireless, non-invasive, continuous glucose monitoring system. Echo claims Symphony is much cheaper to manufacture and much more accurate than current CGM systems.
Echo made a presentation yesterday at the Noble Financial Capital Markets Equity Conference...
Anyway - I thought this is a company right down your alley and am curious what you think.
BTW - I'm Trade2Profit on iHub...
With ECTE's market cap at $135M and a $10B opportunity it looks like it's worth the roll of the dice. I also like the prospect of needle free continuous drug dosing - that would be huge for the painkiller market.
more from JMP...
The market opportunity remains substantial. Despite the availability of other CGM systems, penetration into the Type 1 market is limited to 3-5%. Moreover, the hospital inpatient market remains devoid of any CGM solutions that balance the accuracy, speed, and cost requirements of that environment. We believe the market opportunity is, at minimum, $1.2B but could easily be 10x that given the increasing call for tighter glycemic controls in the inpatient setting.
• Milestones. We expect FDA approval of the company's Prelude SkinPrep system by the end of 2011, completion of the next pilot trial within second half of 2011, initiation of the company's IDE
trial for the Symphony tCGM system in the first quarter of 2012, completion of the IDE trial by mid 2012, and approval of the Symphony by the end of 2013.
• Management believes that the company may be required to perform a 200 patient study, each
of whom will have blood draws every 15 minutes for 36 hours. We expect this trial to be
completed by mid 2012. As a comparison, Dexcom only studied 91 patients in its pivotal trial.
• In addition, we would not be surprised to see the company need to perform a "repeated use
and replacement" trial. In practical use, the Symphony requires moving the sensor to another
part of the abdomen every day; this at least raises the question as to whether this introduces a
source of variability. Dexcom had to run similar clinical trials in 2005/2006.
• The FDA may require the company to perform separate PMAs for the personal CGM and the
hospital markets given that the needs (and the product design for each market) are different.
In terms of reimbursement, the environment has gotten better but remains far from ideal.
Reimbursement was initially a limiting factor in the growth and adoption of CGM technologies because these were such a novel devices that CMS did not have established coding and billing procedures in place. Dexcom, Medtronic, and Abbott have all worked together with key payors to improve the environment. Patient-focused organizations like the Juvenile Diabetes Research Foundation (JDRF) have also driven support for these products, even going as far to fund clinical trials to drive the reimbursement process. At present, reimbursement exists for Type 1 patients, but hurdles still remain for Type 2 diabetics due to the lack of data in this population. Moreover, CGM products are not approved under a national coverage decision by Medicare. As of 4Q10, the seven largest private thirdparty payors cover CGM, but each company in the space has reimbursement specialists to help patients navigate the process. In general, patient copays for CGM range from 10-20% of the total price. Reimbursement for physicians is well established. CGM training Medicare reimbursement is $128, interpretation of CGM data is $40, and pre-/post CGM evaluation is $92-125.
JL - pretty good road map from the JMP Securities research report...
The FDA has recently classified all continuous glucose monitoring systems into a newly created medical device category called Class IIb. Unlike the 510(k), which was deemed too easy, the Class IIb set of devices require clinical information, manufacturing information, and potentially additional evaluation in the post market setting. The key issue for the agency was how to entice manufacturers to improve meter accuracy while balancing the needs of the patient population.
Under the FDA's current requirements for point of care (POC), readings may register up to 20% when measuring glucose concentrations of >75 mg/dL. For blood glucose values less than this level, the FDA permits deviations up to 15% from standardized concentrations. Unfortunately, this error allowance forPOC meters renders them unable to reliably detect hypoglycemia, a potentially deadly consequence for diabetics. Similarly, the allowance permits some normal levels of glucose values to incorrectly display concentrations suggestive of hypoglycemia, which may result in unnecessary and potentially dangerous insulin treatment of hospitalized patients.
For companies like Echo and Dexcom (which is currently in the midst of developing a next generation CGM), this heightened awareness on the part of the FDA of the need for greater accuracy in all CGM systems raises the bar for approval. In the past, these companies would simply file a 510(k), but, given the regulatory environment, we fully expect Echo to run a PMA for the Symphony. While Dexcom has paved the way with its Gen 4 device discussions with the FDA, we need to be absolutely clear on the point that the FDA has not yet cemented its requirements for an approval of a new CGM system. This is one of the key reasons we assume that the Symphony may not be approved until the end of 2013. That said, we believe that the data published to date and an improving (albeit still amorphous) regulatory environment give us confidence that pursuing a personal use CGM has a high likelihood of ending in an approval.
Management has already established an ongoing dialogue with the FDA about its upcoming
clinical trials and remains optimistic that the tenor of the conversation remains both positive and
collaborative. In our opinion, an approval in the hospital setting is harder to obtain than an approval for personal use, but we also view the risk as worth it. The FDA does view CGM as being potentially beneficial to inpatients, but the same error allowances that may be tolerable in the personal CGM market can lead tomuch more severe consequences when dealing with patients who are in recovery. Moreover, the FDA is concerned that anemia, shock, dehydration, and a host of other things could cause erroneous readings in any point-of-care or CGM system - something that would not normally be an issue outside the hospital. The gold standard clinical chemistry glucose measurement tools in the hospital are stillclinical chemistry machines like the YSI. There are no CGM devices approved for use in the U.S., and Dexcom/Edwards have hosen to pursue the European market before trying to get approval for their devices in the U.S.
A non-invasive system may have a lower hurdle because of the lower risk/reward profile. Unlike
invasive systems, the Symphony carries no risk of infection or cross-contamination, and that may play a role in the company's discussions with the FDA may ultimately help shape the company's PMA strategy. While DexCom's pivotal trial for its first generation can serve as a guideline, we are conservatively assuming that the approval hurdle may likely be higher than the one set in 2005 when DexCom's first product was approved.
Sounds very promising...As you know, it is a lot easier to get "devices" through the FDA. In cosmetic surgery we have many FDA approved devices, many of them of questionable value...most importantly they do not hurt anyone.
Glucose monitoring is different. Data from Tufts on accuracy would be important..Do you know where the device stands as far as FDA approval?...P1,P2...P3...etc....
I think the Diabetes ap sounds more interesting than the painless injection. The pain of injections is not simply the needle going through the skin, but the pain of the injection of the substance infitrating the deeper tissues. There are multifactors, pH, chemical structure and amount of pressure exertedon the tissue...it is much more painful to inject into firm tissue or scarred down areas...
Keep up the DD...This could be a good opportunity...
Thnx for the kind words...
Don't know much about ECTE or the prelude system...but it sounds interesting and will check it out...
The increased use of Botox and fillers and the shift in plastic surgery and other types of surgery away from general anesthesia toward lower levels of anesthesia and sedation makes the search for "painless" injections more important...
A majority of cosmetic procedures can be done under local. The worst part of the procedures are the injections which are the main reason for sedating patients in my practice.
Currently Lifestyle Lift a nationwide corp specialising in facial aging procedures uses only local anesthesia with PO sedation for all surgeries...but the injections are very painful..
Topical anesthetics for the skin take too long to set up to be practical in my practice and do not anesthetize the underlying sub cutaneous layer which would be necessary for a truly sucessful product...Such a product woyuld be a huge advance...
Thnx for the info ...Will check it out...
Regards ":>) JL
You may not like what I am going to say...
Back in the mid 90s there was a company we called BICO...It was a penny number which I believe was also out of the Philadelphia area. They also claimed to be working on a transdermal Glucose monitoring system and were already getting great results...
I actually bought some at .35$ and dumped it at .85$ and made a few thou..I bought in later over one dollar and the PPS spiked to $10 for about 40 nano secs...and I got out at $4. From there the the stock disappeared. It was a scam..
Good scams require something with a large potential customer base in dire need of your invention...Diabetic sugar monitoring fits this criteria to a tee.
The reason why such a device does not currently exist is not likely because no has thought about doing it before...the financial rewards would be staggering...Glucose unlike hemoglobin does not register wave length changes as the concentration changes...So how could you monitor it...Maybe there is some other blood change (magnetic, reflectived..???) But how can you invest if you do not understand how they are doing this...The Flux-Capacitor problem..
Can you make money on something like this...Certainly if you can identify a scam..and you can sit by your computer long enough, you might be able to make a score ... good luck..
I watched the video, I am a vet,(DVM), not am MD. A reduction in pain is very different than painless. Painless would would be very big.
The monitoring of blood glucose would be huge if it worked. The skin is constantly growing and new "dead skin" is being produced. How long would you get accurate results? They leave that out.
Very long on AMRN